A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma

This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase IX (CA9)-expressing clear cell renal cell carcinoma (ccRCC). The primary objective is to evaluate the safety and tolerability of PD-32766T, and to characterize its pharmacokinetics and preliminary antitumor activity. Participants will first undergo imaging with PD-32766D to assess CA9 expression. Subjects with positive tumor uptake will be eligible to receive PD-32766T

Trial Details

NCT ID
NCT07688187
Phase
PHASE1
Sponsor
PeptiDream Inc.
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • PD-32766D (a Copper-64 [64Cu] labeled peptide)
  • PD-32766T (an Actinium-225 [225Ac] labeled peptide)
Locations (sample)
  • Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility Criteria

  • Male or female participants aged ≥18 years.
  • Participants with confirmed diagnosis of ccRCC will be included based on the following characteristics:
  • Histological confirmed locally advanced, unresectable, or metastatic ccRCC, after all available standard therapy.
  • Presence of evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) guideline (defined by RECIST v1.1).

For full eligibility, visit ClinicalTrials.gov.

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